Bioavailability Study of Duloxetine Delayed-Relase Capsules 60 mg Under Fed Condition

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02291341
• Date of registration: 11/11/2014
• Prospective Registration: No
• Primary sponsor: Dr. Reddy's Laboratories Limited
• Public title: Bioavailability Study of Duloxetine Delayed-Relase Capsules 60 mg Under Fed Condition
• Scientific title: Single Dose Crossover Comparative Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg in Healthy Adult Human Subjects Under Fed Conditions
• Date of first enrolment: May 2008
• Target sample size: 76
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02291341
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

India

Contacts

• Name: Dr.Ronak Modi, MBBS
• Affiliation: BA Research India Ltd

Key inclusion & exclusion criteria

Inclusion Criteria:

1. The subjects should be healthy human between 18 and 45 years.

2. The subjects should be screened within 21 days prior to the administration of first
dose of the study drug.

3. The subjects should have a BMI between 18.5 and 24.9 weight in kg/ height2 in meter.

4. The subjects should be able to communicate effectively with study personnel.

5. The subjects should be able to give written informed consent to participate in the
study.

If subject is a female volunteer and

6. Is of child bearing potential practicing an acceptable method of birth control for
the duration of the study as judged by the investigator(s), such as condoms, foams,
jellies, diaphragm, intrauterine device (IUD), or abstinence.

7. Is postmenopausal for at least 1 year.

8. Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or
hysterectomy has been performed on the subject).

Exclusion Criteria:

1. The subjects who have a history of allergic responses to Duloxetine or other related
drugs.

2. The subjects who have significant diseases or clinically significant abnormal
findings during screening, medical history, physical examination, laboratory
evaluations, ECG and X-ray recordings.

3. The subjects who have any disease or condition which might compromise the
haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central
nervous system, diabetes, psychosis or any other body system.

4. The subjects who have a history or presence of bronchial asthma.

5. The subject who have used enzyme-modifying drugs within 30 days prior to receiving
the first dose of study medication.

6. The subjects who have history of drug dependence, recent history of alcoholism or of
moderate alcohol use.

7. The subjects who are smokers, who smoke more than or equal to 10 cigarettes per day
or more than or equal to 20 biddies per day or those who cannot refrain from smoking
during study period.

8. The subjects with a history of difficulty with donating blood or difficulty in
accessibility of veins.

9. The subjects who have donated (1 unit: 350 ml / 450 ml) blood within 90 days prior to
receiving the first dose of study medication.

10. The subjects who have a positive hepatitis screen (includes subtypes A, B, C & E).

11. The subjects who have a positive test result for HIV antibody and / or syphilis
(RPR/VDRL).

12. The subject who receives an investigational product, or has participated in a drug
research study within a period of 90 days prior to the first dose of the study
medication administration.

13. Female volunteers demonstrating a positive pregnancy screen.

14. Female volunteers who are currently breast-feeding.

15. Female volunteers not willing to use contraception during the study.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Duloxetine

Drug: Cymbalta®

Primary Outcome(s)

Area under curve (AUC) [Time Frame: 1.0, 2.0,3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 11.0, 12.0, 24.0, 36.0, 48.0,60.0 and 72.0 hours post dose]

Secondary ID(s)

BA0859089-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors